MX2008014060A

MX2008014060A - In-situ measurement of phyisical parameters.

Info

Publication number: MX2008014060A
Application number: MX2008014060A
Authority: MX
Inventors: Shamus Husheer
Original assignee: Cambridge Temperature Concepts
Priority date: 2006-05-04
Filing date: 2007-05-04
Publication date: 2009-03-06
Also published as: BRPI0711559A2; PL2020923T5; GB0608829D0; JP2009535141A; JP5256191B2; ES2414611T5; PL2020923T3; CN101460100A; CN101460100B; EP2020923A2; EP2020923B1; EP2020923B2; US8540644B2; RU2008147709A; US20090234200A1; ES2414611T3; WO2008035151A3; WO2008035151A2

Abstract

A data logger device for in-situ measurement of one or more physical parameters comprising a power source; one or more sensors for measuring the one or more physical parameters; a data store for storing representations of at least some of the measured values of the one or more physical parameters; control logic arranged to write the representations of at least some of the measured values to the data store and arranged to read data from the data store during data transmission; an antenna; and a transmitter coupled to the antenna and configured to transmit the stored data by passive transmission.

Description

IN SITU MEASUREMENT OF PHYSICAL PARAMETERS FIELD OF THE INVENTION This invention relates to a data recording device for in situ measurement of one or more physical parameters, to a system for in situ measurement of one or more physical parameters, to a system for determining the ovulation point in a female subject, and a system for in situ temperature measurement.

BACKGROUND OF THE INVENTION Data storage devices for measuring and storing physical parameters are widely used across the engineering and scientific worlds. Such devices allow the automated monitoring of physical parameters in situ during long time scales, in hard-to-reach locations or in environmentally hazardous conditions-situations in which manual measurements can be inconvenient or time-consuming. One such data logging system that has been developed is the MiniMitter system (http://www.minimitter.com) to record temperature. However, the cost of the total solution is rather high, and the data recorded by themselves is rather cumbersome and very REF. : 197871 great for many applications. In particular, the periodic measurement of several physiological parameters is essential for many medical conditions, the parameters in the range from body fluid pressure and conductance for temperature and gradients. Of temperature. Physiological parameters can be measured "by hand", for example, by the doctor or nurse, or can be reviewed by (often expensive) medical devices to which the patient requires to remain connected for the duration of such measurement in question. The situation is even more acute for those people who need to measure certain physiological parameters in a home environment (such as diabetics). Without support structures placed in clinics or hospitals, patients most likely forget to take the required measurements, or they may encounter inconveniences in time, and may not be able to access medical equipment in the first place.

BRIEF DESCRIPTION OF THE INVENTION There is therefore a need for an automated, inexpensive recording of physiological parameters by in situ measurement devices. Such devices could reduce the burden of medical personnel, reduce the possibility that measurements will be lost and, because the The device would remain in place at the required measurement location, potentially reducing the number of painful or invasive measurements the patient has to endure. Additionally, measurements can be taken without interruption to the patient, for example, during the time he sleeps or a busy daily schedule. For certain physiological parameters, or long-term medical conditions, an implantable device should better facilitate the measurement of these parameters. It is desirable that implantable medical devices have a life span as long as possible within the patient, in as small a volume as possible. In many devices, this is limited by a tradeoff between battery life and battery size, and removal and reinsertion of the device is necessary simply for the purpose of recharging or replacing this battery. This causes undue stress and discomfort for the patient. In particular, women sometimes want to regularly measure their body temperature in order to determine the point at which they are possibly ovulating each month. This "natural method" is attractive to many women who seek to conceive and can also be used as a way to avoid pregnancy, perhaps by a woman with particular religious beliefs. For the most reliable results, regular temperature measurements are required during most of the ovulation cycle. European Patent Application No. 0195207 describes a uterine implant for periodic recording of temperature data, which is wirelessly transmitted to an available receiver for request analysis and display. This solves a major problem in the use of the Basal Body Temperature (BBT) method for natural family planning, in which the user does not need to be incorporated, nor even remember to take temperature measurements, on a daily basis. Unfortunately, the device must be removed periodically and reinserted due to the need to replace or recharge the battery in the device. Although it is introduced into an accessible body cavity, this withdrawal and reinsertion procedure is highly inconvenient and has important associated medical risks. Alternatively, an implant device that does not store the data measurements in the implant device but transmits the measurements directly to a reader could be used. In this case the energy for the implant can be supplied by the reader, such as in European Patent Application No. 0476730. This is common for passive radio frequency identification (RF-ID) sensors. However, this system requires that the implant be located near the RF-ID reader provided that the implant device is for making measurements. In data logging systems that use a rechargeable battery, the battery life is limited since the battery will only accommodate a certain number of recharge cycles before the battery's performance falls to a level that does not sustain a charge reasonable for operation of the data logger. This is a particular problem for an implanted data logger, for which a lifetime of the order of 10 years is desired to maintain the required frequency of minor operations to replace the implant to a minimum. A passive system has been suggested in European Patent Application No. 0746040, which describes a passive transponder that includes an integrated sensor. The transponder is operated to receive an interrogation signal from a scanner and transmit identification information and bodily information to the scanner. However, the system does not provide data logging capabilities and therefore requires the scanner to be coupled to the transponder whenever measurements are required. According to a first aspect of the present invention there is provided here a data recording device for in situ measurement of one or more physical parameters comprising: a power source; one or more sensors to measure one or more physical parameters; a data warehouse for storing representations of at least some of the measured values of one or more physical parameters; logic control configured to write the representations of at least some of the measured values to the data store and configured to read data from the data store during data transmission; an antenna; and a transmitter coupled to the antenna and configured to transmit the stored data by passive transmission. Preferably the power source is a rechargeable power source and the transmitter is configured to supply at least part of the electromagnetic energy received in the antenna to the rechargeable power source so as to recharge the rechargeable power source. The data recording device may further comprise a selector logic, with the transmitter being configured to supply at least part of the electromagnetic energy received in the antenna to the rechargeable power source if the selector logic selects that the rechargeable power source It is rechargeable. The selector logic can be configured to select that the rechargeable power source is rechargeable if the voltage across the power source falls below a predetermined level. At least some of the representations of the measured values can be a difference between a previously measured value and a subsequently measured value of a parameter physical Preferably the control logic is configured to write at least some of the representations of measurement values to the data store in conjunction with a time stamp indicating the time at which the respective measurements are taken. Preferably each sensor is configured to measure one or more physical parameters at a predetermined frequency. Preferably the control logic has a first mode of operation in which this is operated to write representations of measurement values to the data store and a second mode of operation in which this is not operated to write representations of measurement values to the store of data, the control logic consumes more energy in the first mode than in the second mode, and the control logic is configured to enter the second mode of operation when one or more of the following conditions meet: (a) a length Default time elapses after writing to the data store; (b) when the value to be measured from one selected one of one or more physical parameters changes between the measurements by more or less the predetermined amount; (c) when the value to be measured from one selected from one or more physical parameters is a value greater than or less than a predetermined value.

Preferably the control logic is configured to enter the first mode in a predetermined period of time after entering the second mode. Preferably the data logger further includes comparison circuitry configured to determine when the value being measured from a selected one of one or more physical parameters changes between the measurements by more or less the predetermined amount, and the comparison circuitry is configured to, in In response to this determination, it causes the control logic to enter the first mode and write representations of at least some of the measured values to the data store. Preferably the data logger further comprises means for averaging a set of measurement values from one selected from one or more physical parameters and causing the control logic to write a representation of the average of the set of measurement values to the data store. The physical parameters may be one or more of temperature, pressure, pH, light intensity, sound pressure, movement, spectral light quality, orientation or inclination of the data logger, and vibration. Preferably the data store of the data logger is configured to store additional data. Additional data may include personal information and / or medical At least some of the one or more physical parameters may be physiological parameters and the data recording device may be incorporated into one of: (a) a package suitable for implantation in a human or animal body; (b) an adhesive patch suitable for use on the skin; and (c) an item of clothing or other item to be worn; (d) a protective envelope. One of one or more sensors can be a first temperature sensor. One of one or more sensors may be a second temperature sensor, and the first temperature sensor is configured to measure the temperature of a human or animal body and the second temperature sensor is configured to measure the ambient temperature of the human or animal body. . One of the one or more sensors may be an accelerometer or other means for measuring movement of the data recording device or the body to which the accelerometer or other means for measuring movement is attached. Preferably the control logic is configured to write a representation of a value that is measured from a first selected value from one of one or more physical parameters to the data store only when the variation in previously measured values of a selected second of one or more physical parameters is less than a predetermined value. Preferably the control logic is configured to write a representation of a value that is measured from one selected one of one or more physical parameters to the data store only when the value being measured changes between the measurements by more than a predetermined amount.

The representation can be a time stamp that indicates the time at which the change was measured. According to a second aspect of the present invention there is provided here a system for in situ measurement of one or more physical parameters comprising: a data recording device as claimed in any of the preceding claims; and a data reading device comprising a receiver configured to receive at least some of the data stored from the data recording device by passive transmission. Preferably the data logger is configured to transmit at least some of its stored data when the energy received by the receiver from the data reader exceeds a predetermined level. Preferably the data logger is configured to transmit at least some of its stored data in response to an appropriate command from the data reader.

Preferably the command indicates which of the data stored in the data logger is transmitted. Preferably each sensor is configured to measure one or more physical parameters at a predetermined frequency and the data reader is operated to transmit a signal to the data logger to establish this frequency. Preferably the data store of the data logger is configured to store additional data. Additional data may include personal and / or medical information. Preferably the data logger is configured to transmit at least some of the additional data once an appropriate command is received from the data reader. Preferably in response to receiving an appropriate command from the data reader, the data logger is configured to (a) overwrite at least some of the additional data with the data transmitted in conjunction with the command, or (b) write data transmitted in conjunction with the command to the data store as extra extra data. Preferably the data reader is operated to transmit an authentication code to the data logger. At least part of the authentication code may be determined depending on the identification code of the data logger. At least part of the code authentication can be determined depending on the identification code of the data reader. Alternatively, the data logger hosts a set of valid authentication codes and the data logger is configured to transmit at least some of its stored data to the data reader only if it receives a valid authentication code. Preferably the data logger is configured to perform the public key authentication of the data reader, or vice versa, and the data logger is configured to transmit at least some of its stored data to the data reader only if it receives a valid response. Preferably the data reading device comprises input means for entering data in the reader. Preferably the data reading device is configured to store at least some of the data received in the data reading device. The data reading device may be operable to transmit by wire or wireless communication at least some of the data received from the data logger to one or more of an internet server, a personal computer (which includes a laptop, desktop computer , PDA, smart phone or handheld), a storage device, or any other data processing device. Preferably the data reading device is configured to process each value that is measured from the first temperature sensor depending on the corresponding measured value of the second temperature sensor so that an estimate of the core body temperature of the human or animal body is formed. that the first temperature sensor is set to measure. Preferably the data reading device is configured to ignore at least some of the measured values of the first temperature sensor that are measured when the variation in measurement values of the accelerometer or other means for measuring movement exceeds a predetermined value.

Preferably the data reading device is configured to ignore at least some of the measured values of the first temperature sensor that are measured when the measured values of the accelerometer or other means for measuring movement exceed a predetermined value. According to a third aspect of the present invention there is provided here a system for determining the ovulation point in a female subject comprising: a data recording device comprising: a first temperature sensor for measuring a first temperature of the subject of the female sex; a data warehouse for storing one or more first temperature measurements as a set of first physiological data; logic control configured to store representations of first temperature measurements in the data warehouse; a transmitter configured to transmit at least some of the stored data; a data reading device comprising: a receiver configured to receive at least some of the data stored from the data recording device; and a data processor having operable input means for receiving at least one other set of physiological data; wherein the data processor is configured to combine the first temperature data of the data reading device and at least one other set of physiological data so that an indication of the ovulation point is formed. Preferably the data recording device is incorporated into one of: (a) a package suitable for implantation in a human or animal body; (b) an adhesive patch suitable for use on the skin; and (c) an item of clothing or other article to be worn; (d) a protective envelope. At least one other set of physiological data may include at least one of cervical fluid quality data, hormone level data, and data indicating dates of at least one previous menstruation.

Preferably the data processor is operated to combine the first temperature data and at least one other physiological data set by means of an ovulation prediction algorithm which is configured to assign a different statistical weight to each of the data sets. Statistical weights can be based on the degree of prior correlation between the ovulation point indicated by the data sets and the current ovulation point. Preferably the data processor or data reader is operated to accelerate the user to provide additional physiological data sets to the input means of the data processor. The data reading device preferably comprises a housing and the data processor may be incorporated within the housing of the data reading device. Preferably the data reading device is a portable device. Preferably the data reading device includes a memory for storing the data received from the data recording device. Preferably the data reading device includes a screen for displaying the data received from the data recording device. Preferably the data reading device is configured to make available by wire or wireless communication with the data processor at least some of the data received from the data logger. Preferably the data recording device further comprises an accelerometer or other means for measuring the movement of the subject of the female sex and the control logic is further configured to store representations of the movement measurements in the data store, the data processor is operates to ignore at least some of the temperature measurements that are measured when one of the following conditions was true: (a) the variation in motion measurements exceeds a predetermined value; (b) the movement measurements exceed a predetermined value. Preferably the data recording device further comprises an accelerometer or other means for measuring movement of the subject of the female sex and the control logic is further configured to not store at least some of the representations of the first temperature measurements in the data store when one of the following conditions is true: (a) the variation in previous movement measurements exceeds a predetermined value; (b) at least one pre-move measurement exceeds a predetermined value. Preferably at least other data sets The physiological data received in the input means of the data processor is movement data for the subject of the female sex and the data processor is operated to ignore at least some of the first temperature measurements that are measured when one of the following conditions was true. : (a) the variation in the measurements represented by the movement data exceeds a predetermined value; (b) the measurements represented by the movement data exceed a predetermined value. Preferably the data recording device further comprises a second temperature sensor and the control logic is further configured to store representations of the second temperature measurements in the data store. Preferably the second temperature sensor is configured to measure the ambient temperature of the female subject and the data reading device is configured to process each measurement of the first temperature sensor depending on the corresponding measurement of the second temperature sensor so that it is formed an estimate of the core body temperature of the subject of the female sex. Preferably the data processor is operated to make a first determination depending on the data from the data logger and / or at least others physiological data sets as to whether the female subject has reached a basal body temperature and, if the result of the first determination is negative, the data processor is configured to form an estimate of basal body temperature depending on at least one of the following: (a) a rate of change in any of the temperature measurements; (b) a ratio of change in the ratio of change in any of the temperature measurements; (c) data that represent previous variations in temperature when the temperature of the female subject approaches a basal body temperature. Preferably the data logger is configured to transmit at least some of its stored data to the data reader by wired or wireless transmission. According to a fourth aspect of the present invention a package comprising a data recording device is provided here, the data recording device includes: a first temperature sensor for measuring a first temperature; a data store for storing one or more first temperature measurements; logic control configured to store representations of first temperature measurements in the data warehouse; and a transmitter configured to transmit at least some of the data stored; and the packet further comprising first and second portions, the data recording device that is held between them; wherein the first temperature sensor is adjacent to the first portion and at least one region of the first portion next to the first temperature sensor has a greater thermal conductivity than the second portion. Preferably the face of the first portion opposite the data logger supports a layer of adhesive so that the package is allowed to attach to an object or body of a human or animal such that the first temperature sensor is close to the object or to the body. Optionally the package further comprises a band or strip configuration configured to fit around a part of a human or animal object or body and, in use, maintain the package to the human or animal object or body such that the first sensor temperature is close to the object or body. Preferably the first portion has a localized opening so as to expose the first temperature sensor of the data recording device. Preferably the first portion has an opening through which the data recording device can be inserted or removed. Optionally, the first and second portions of the package are disposable. Preferably the data recording device further includes a power source and the first temperature sensor is mounted against the power source. Preferably the data recording device further includes a second temperature sensor for measuring a second temperature. Preferably the second temperature is the ambient temperature of the package. Preferably the second portion has a localized opening so as to expose the second temperature sensor of the data recording device.

BRIEF DESCRIPTION OF THE FIGURES The present invention will now be described by way of example. In the drawings: Figure 1 is a schematic diagram of a data recording device; Figure 2 is a circuit illustrating the principle of passive data transmission. Figure 3 illustrates the relationship between a data record, a data reader and a data processor according to an embodiment of the present invention. Figure 4 is a representation of a data record incorporated within an adhesive patch.

Figure 5 is a representation of a data record and disposable adhesive patch. Figure 6 shows (i) a BBT graph as estimated by a prototype data record according to an embodiment of the present invention and (ii) a graph of the average of two measurements of body temperature taken at 6.30. am with a Braun ThermoScan. Figure 7 is a circuit diagram of a prototype data logger according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION Figure 1 is a schematic diagram of a data recording device 100 according to the present invention. In the data recording device of Figure 1, the control logic 112 samples the signals from one or more sensors 106 and stores the result in the data store 110. In the preferred embodiment, the control logic includes an analog converter to digital (AD) which converts the analog signals of the sensors 106, 108 to digital values for storage in the data store 110. The control logic 112 further includes a stopwatch to allow periodic storage of the sensor values at regular intervals . At least part of the control logic to record or store a recorded temperature is energized by the power source 102. The transducer 116 is operated to transmit data stored in the data store 110. In order to minimize the drain in the power source 102, in a preferred embodiment, any logic necessary for the transmission of data takes its energy from an electromagnetic field coupled to the antenna 114, to which the transducer is connected. Antenna 114 is preferably a coil of wire with a core having a high relative permeability, such as ferrite. Data transmission is possible when the transducer is coupled to an appropriate oscillating electromagnetic field, such that it can be provided by a data reader. The data transmission therefore does not require any net power from the power source 102. The data transmission in the present invention preferably operates according to the principles set forth in Figure 2. Alternatively, any of the known methods of passive transmission known in the art (particularly in relation to RFID systems passively) can be used. The transducer 116 can be considered to comprise a transmitter and receiver. Here "transmitter" is taken to mean any element or group of elements that can carry out the transmission of data by any means.

"Receiver" is taken to mean any element or group of elements that receives energy and / or data from an electromagnetic field to which it is coupled (preferably by means of an antenna). A circuitry element may be identifiable as part of both a transmitter and part of a receiver. In a passive transmission system, the energy can be transferred in one direction and the data in another. Figure 2 is a circuit illustrating the principle of passive transmission used by many RFID systems passively. Typically, a radio frequency signal is generated in the reader 204 by the generator 208 that drives the reader circuit 205. The transponder 202 receives power from the reader 204 by means of electromagnetic coupling between the reader circuit 206 and the transponder circuit 205. The oscillating voltage induced in circuit 216 is rectified by diode 212 to provide a useful voltage between terminals 214. This voltage can be used to drive the circuitry. In particular, the energy received in the transponder can be used to drive the transmitter circuitry. The circuitry of the transmitter in Figure 2 is represented by a switch 210 which cuts the capacitor 207 when it closes. When opening and closing the switch 210 the resonant frequency of the LCR 216 circuit can be changed between two values. This again determines the extraction of energy by the circuit 216 from the oscillating field generated by the circuit 206. It is more conventional to consider that the circuits 205 and 206 form a transformer: changing the resonant frequency of the circuit 216 by changing the load in the circuit 205 This change in charge can be detected in the reader by means of a detection circuit 209, which can be an ammeter. In this way, the digital data can be sent from the transponder 202 to the reader 204 by simply switching between the two resonant states of the circuit 216 by means of the switch 210. Typically only one of the resonant frequencies of the circuit 216 is at or near the frequency generated by the generator 208. This provides a strong change in the load in the circuit 205. Preferably, the power source 102 is rechargeable.

Since the transducer 116 is operated to derive energy from an oscillating electromagnetic field in the antenna 114, the transducer can supply power to the rechargeable energy source. Additionally, since the transducer transmits passively, it requires an electromagnetic field incident from the reading device in order to transmit data to the reader. The reader can provide a field to provide power to the data logger and a separate field to allow passive data transmission by means of field manipulation by the data logger.

The data logger may further provide with a second antenna and additional transducer circuitry. Preferably the two fields are one and the same. Preferably the power source 102 is a rechargeable battery. Most rechargeable batteries exhibit a reduced capacity to store charge during a number of recharge cycles. In an application where the battery can be recharged daily, you still need to have the capacity of months in charge value, this can have an adverse effect on the life of the battery. It is therefore optimal to recharge the battery only when required, as when it reaches a level, minimum load. However, the data logger described here does not need to be able to request a recharge - in this case you should take advantage of the recharge when it is presented. Therefore, to minimize degradation in battery performance caused by an excessive number of recharge cycles, the protocol is based on the estimated charge that can be used, and / or the remaining battery charge as indicated by the voltage of the battery (under charged and / or discharged conditions). A selector logic can be provided to select whether or not the power source is rechargeable. The logic of the selector can allow the power source to recharge when the voltage crossing the power source falls below a predetermined level. Level default can be stored in the manufacturing logic of the selector. Alternatively, the selector logic may allow the power source to recharge when at least a predetermined time elapses since the last recharge. The recharge selection can be made by turning the pass-through element on or off (such as a transistor) under certain conditions as dictated by the logic of the selector. In a preferred embodiment, the transducer receives its energy from an oscillating electromagnetic field generated by a reading device. The data recording system according to one embodiment of the present invention is illustrated in Figure 3. The reading device 307 can be held in the hand and therefore can be easily placed by the user in a way that efficiently coupled between the reading device and the data recording device 301. The reader may include a screen 303 to allow the visibility of the received data or to provide a visual menu interface to the user. The reader can be supported by battery or physically connected to a second device, such as a processor device 309 to process the received data. The data can be sent from the reader to the data processor wirelessly or by wire communication. Alternatively, the data processor can be part of of the data reader. The reader may include one or more inputs, such as a keyboard 305, by means of which the user may interact with the reader or enter data in the reader. The data processor may include one or more inputs 311, allowing the input of additional data sets to the data processor or to allow interaction with the data processor / reader functionalities. As indicated by the dotted border in Figure 3, the data reader and data processor may be part of the same device, or they may be separate devices. The data logger may further comprise a logic receiver for interpreting one or more commands received in the transducer and encoded in the electromagnetic field provided by the reader. The data can be sent to the data logger by switching the frequency or amplitude of the electromagnetic field, or by any other transmission techniques known in the art. Preferably the logic of the receiver can also be energized by the energy taken by the transducer from the electromagnetic field. The reader can send one or more commands to the data logger. These may include commands to set the sampling interval of sensors 106, a command to initiate data transfer, and also configuration commands, such as calibration constants, codes ID, restart commands and updates for any logical control implemented as firmware. Alternatively, the calibration factors, sampling interval and recorder ID are set during manufacturing. In one embodiment the transducer initiates the transmission of the stored data once the energy received in the transducer exceeds a predetermined level. Alternatively, the transducer initiates transmission when a signal is received from the reader. Preferably the reader transmits an identifier to the data recorder which includes an identification code. The data logger will only transmit the stored data to the reader if the identification code matches a code stored in the data logger. The data logger can (a) store one or more identification codes that correspond to one or more data readers or (b) the data reader may be required to transmit the unique code of the data logger. The identification codes can be stored in the data store 110. Preferably the data logger does not transmit its code and in this case in case (b) the reader requires to have prior knowledge of the code. This helps protect the data store in the data logger from unauthorized or undesired revision. Alternatively, the use of protocols Known cryptography can be used to provide enhanced security, such as protocols that "respond to challenges", or others known in the art. The data logger can store data in the data store 110 other than the signals of the sample sensor. This may include one or more identification codes as discussed above, and / or data relating to the user, such as personal identification information or medical information. This is particularly useful in the case where the user is a patient and the data logger is used for physiological parameters of a patient's record: the medical information could be general identification information of the patient or the results of previous medical tests or notes observational. These other data can also be sent to the reader. A reader may need to provide different identifiers in order to receive different types of data. For example, a first identifier may require triggering the data logger to transmit the stored physiological parameter data and a second identifier may require triggering the data logger to transmit the user / patient information. The data store 110 is preferably a non-volatile memory, such as a RAM, EEPROM, FLASH RAM, or more preferably FRAM or MRAM supported by a battery. The fountain of energy 102 can be a capacitor or battery. In one embodiment, at least one of the sensors is a temperature sensor. Preferably the temperature sensor is a thermistor. Alternatively, the temperature sensor may be a silicon-based device, such as a voltage source "proportional to absolute temperature". To increase the sensitivity the signal can be stimulated by signal conditioning elements, such as bridges, filters, and amplifiers. In order to minimize the size and power requirements of the data logger, where the data logger circuitry is possible, it is manufactured as a simple microplate. In the case of a data recording device for measuring one or more physiological parameters, the device can be provided as an implant (sub-dermal) or as a patch to be used. As an implant the data logger housing is preferably inert and coated to help prevent rejection by the host immune system. Examples of physical parameters that can be measured by the data logger are temperature, pressure, pH, light intensity, vibration, sound pressure, orientation or movement. Examples of physiological parameters that can be measured by the data logger are temperature body, blood pH, blood glucose, pulse rate, blood pressure. These parameters can be measured by any of the methods known in the art. A data recording device according to the present invention can be configured to measure body temperature in a manner that allows automated determination of basal body temperature. This allows the ovulation point to be estimated from one cycle of ovulation to the next by appreciating an elevation in the basal temperature (minimum rest) for a number of days. This is substantially independent of short-term variations in user's skin temperature, which can vary rapidly through each day as a result of changes in activity level, environmental temperature etc. Since body temperature typically varies slowly, several improvements can be made to the data recording process. A first improvement is to compress the data from the sensor to the data logger. A data stream of the differences between the previous and present measured temperature is a good candidate for "entropy coding" or any other means to minimize the memory requirement for values that occur frequently compared to values that occur less frequently. This allows a larger number of measurements to be stored in the data logger.

By using an appropriate compression scheme, for example Fibonacci coding, it is possible to separate individual data points. The data can be read simply from a circular buffer with an error introduced only in the last two measurements in memory, which can be easily discarded. Data that is not recorded in a fixed interval may require that the record (for example a time stamp) be maintained from when the data (or data groups) were measured. For example, if the memory is full, old values can be replaced with new values and a time stamp ensures that it is known when each sensor value was measured. A second improvement is to record only a time stamp when the temperature changes by more than a predetermined amount (for example 0.01 degrees) from the last measured value. The measurements can be taken at a predetermined frequency or the sensors can be checked essentially continuously for changes in temperature. The value or difference in temperature may or may not be registered with the time stamp. By recording the differences over time the data is ready for compression, as described above. Often the small rapid fluctuations in the sensor values are not important, such as in the Temperature measurements to determine the ovulation point. In such cases a very simple A / D converter or a sample and maintenance circuit can be used to perform the comparison of the temperature values in order to determine the difference between the last and current values. A main A / D converter can be kept in a sleep state until the difference is greater than a predetermined amount and the time stamp and / or the temperature value is to be stored in the data logger. This scheme could also be increased with a minimum sleep time in order to prevent the main A / D converter from waking up very frequently during periods of larger rapid temperature fluctuations. These schemes help to save both memory and energy in the data logger. A third improvement is averaging the values over time. This has the effect of discarding information about rapid fluctuations in sensor values, essentially by removing high-frequency "noise". This can be achieved through the use of a sliding window: for example, a circular buffer can hold the last 16 measurements, measured at a resolution of 14 bits, and an average of 16 bits of measurements should be stored in memory. The sum of these measurements of 14 bits is a number of 18 bits but, assuming that the distribution of Gaussian noise in the last important bits of the signal A / D, an improvement in the signal: noise of sqrt (16) = 4 would occur: using only the 16 bits The higher of the 18-bit number provides a 16-bit value for the 14-bit measurements. Other lengths in bits and round buffer sizes could be used. A further improvement would be to not include the maximum and minimum measurements in the buffer in the averaged calculation. This helps minimize the effect of remote measurements. Some numbers of measurements could also be selectively excluded, for example only the 12 half measurements of 16, to further reduce the effect of short periods of remote measurements. Natural Family Planning works by monitoring certain physical signals that occur during the menstrual cycle. The most common signs that are observed are menstrual bleeding, changes in the cervical mucus and changes in body temperature. The calendar rhythm method is the oldest and most widely practiced method of fertility awareness. The calendar graphics allow the woman to estimate the start and duration of time when an egg is available for fertilization by sperm. The calculation of the fertile period is made from three assumptions: 1) the Ovulation occurs on day 14 (more or less two days) before the start of the next period; 2) the sperm survive two to three days; 3) the egg, or egg, survives 24 hours. The basal body temperature (BBT) method is commonly used when taking an oral temperature at first hour, preferably at the same time each morning, and grouping these temperatures on a graph. Ovulation is usually indicated by which it occurs after three consecutive days where the temperature is higher than any of the previous 7 days. Using this method, ovulation is not predicted, but it can be identified once it has been presented. This method is more useful to identify when the infertile time of the woman has begun. Changes in the cervical mucosa have a distinctive pattern among the majority of women who ovulate, even those whose cycles are irregular. To evaluate the cervical mucus, a woman gets some mucus from her vaginal opening. When checking her mucus, the woman needs to determine if she feels wet or dry. The quality of the mucus such as stickiness, elasticity and humidity suggests if she is in her cycle. The release of the egg usually passes the day before or during the last day of "slippery, wet" mucus. Fertile time occurs when the mucus has the characteristics of a raw egg white. The use of lubricants or douching can make these characteristics more difficult to recognize. The different graphing methods can be used alone or in combination. A common technique is for the woman to record changes in her mucus and record her basal body temperature. Some women also report and report ovulatory pain that may include sensations of heaviness, abdominal swelling, rectal pain or discomfort, and lower abdominal pain or discomfort. Pain may occur together before, during or after ovulation. The data recorder described herein can perform the aspect of automatically monitoring the temperature, while the woman would need to keep a record of the other subjective parameters such as changes in the mucus by itself. By entering these additional subjective parameters into the reading device (as described above) or into a data processor to which the temperature data is sent, and making use of it only when it is available (although it does not need to be available) , can be combined selectively with temperature data and time / date data to estimate future ovulation dates, and also future dates for expected changes in subjective parameters, causing the woman to be monitored when she is most likely to need it. The importance of these subjective parameters additional is that the temperature rises AFTER ovulation, while other subjective parameters change BEFORE ovulation. If you are trying to identify the fertility window using only temperature, the window of uncertainty is wider because the part of the post-ovulation cycle is well defined (typically 10-12 days or so before menstruation), and not It varies a lot in length from cycle to cycle. Therefore the recorded temperature can identify this period. However, the part of the cycle prior to ovulation is variable length cycle to cycle. When adding data about the first day of menstruation, a second completely objective parameter has been added and the estimation of ovulation time can be improved. By adding information about the quality of the cervical mucus, for example, the start of the fertile window can be determined more accurately. However, the quality of the cervical mucus is very hard to establish trustworthiness for some women, particularly after the previous day's sexual encounter. It is more beneficial if additional physiological data are used only when they are provided, and the system depends on the temperature and rhythm measurements to calculate the start of the fertile window when they are not provided. Similarly, other parameters such as output quality, sensitivity of the Breast, ovulatory pains, and hormone measurements can all be added if observed. A data recording device for monitoring body temperature can take the form of an implant that is injected into the female subject or inserted into a minor operation. The data logger is preferably inserted into the abdomen or the inside of the forearm so that the temperature recorded by the data logger is an accurate reflection of the actual core body temperature. Alternatively, the data logger may be incorporated into a patch, usable band or an article of clothing (such as underwear). This implement is described immediately. Figure 6 illustrates the benefit of using an ambient temperature data recorder to estimate basal body temperature. The first determination in Figure 6 is of daily basal body temperature as estimated from the data recorded periodically during the night while the user was asleep by a prototype data logger according to an embodiment of the present invention. Temperature measurements taken during periods of high movement were ignored and the remaining temperature data from the data logger was processed to remove the remote temperature measurements. An average of the remaining temperature measurements was then taken to eliminate fluctuations of short duration in the measured temperature. The second determination is of basal body temperature during the same days as the first estimate estimated using a conventional technique: two measurements were taken by the user with an aural thermometer (a Braun ThermoScope) at 6.30 am once he wakes up. The prototype data logger clearly detects the ovulation date (indicated by arrows in the determinations) while it is very difficult to detect using the conventional approach. The use of the data logger also removes the need for the user to wake up early each morning, take his temperature and write it down in a logbook. Figure 7 shows a circuit diagram of the prototype data logger used to collect the data shown in Figure 6. By sorting the regular read data from the data logger (so that ovulation is predicted) the power source is recharged regularly of the energy derived from the electromagnetic field generated by the reader. The energy source for the device can therefore be relatively small. This combination of small device size and wireless recharge during data transmission allows a practical implementation of the device as an implant, or alternatively allows the device to be discreetly incorporated into a small adhesive patch that can be fixed to the skin in the same manner as a regular sticking plaster or bandit. In one embodiment, the data recorder includes an integrated circuit that contains a logic control, coordination, measurement, energy control, temperature sensing, and wireless communications, which are attached to a lithium polymer battery for energy storage, and the antenna. Because the data logger measures the body temperature, the temperature range that the device is exposed to is very close and thus a very low energy analog coordination for the sampling frequency is possible with acceptable accuracy using R-C time constants. The change in the energy supply during the time can also be measured periodically and in this way the measurement frequency can be calibrated during the recording. Typically the data registers registered at a predetermined frequency (for example every 10 minutes), and records in this memory. The system for determining the ovulation point may comprise the data logger in any of its forms described herein and which is configured to measure temperature, a data reader in any of its forms described herein and a data processor.

Alternatively, the data logger can be any temperature data recorder known in the art capable of passive transmission and with which the data reader is compatible. The data logger transmits its stored data to the data reader by passive transmission. The data reader and data processor can communicate by any means known in the art. The reading device may have a screen and user input capability so that it allows the user to see the tables or graphs of the data received from the data logger, and / or allow the user to interact with the graphic menu systems. The reading device can be connected to a data processor or the data processor can be part of the reading device. It is only important that in some aspect of the system it is capable of processing. the data received from the data recorder so as to provide an indication of the ovulation point in the subject of the female user. The data processor can simply be a personal computer that supports software configured to perform data processing. Either the data reader or the data processor includes input means for entering at least one other set of physiological data for the subject of the female user. The data processor can combine the temperature data with the other physiological data sets (such as cervical mucus quality, blood or urine hormone test results, etc.) to provide an indication of the ovulation point according to any of the detection principles of ovulation described above or known in the art. Preferably the reading device consists of a portable wireless reader with a two-way communication with the implant when activated in an appropriate proximity. The user interface can include a number of buttons, to enter such data as menstruation days and cervical fluid quality, and a simple LCD screen that warn of measurements or indicate parameters such as implant and battery charge of the reader. Likewise, the user can enter any of the additional physiological data in the data processor if the data processor is configured to receive such inputs - this would be convenient for the user if the data processor is a personal computer. The reader itself may be able to estimate the ovulation point based on previously recorded data that can be stored in the reader and / or the data processor), and is able to properly display the expected number of days until the following ovulation of the user. For privacy reasons, the device may preferably not exhibit any Information regarding fertility unless you recently contacted the implant that is keyed.

The reader device may contain a USB port (or other appropriate form of wired or wireless connectivity) to allow connection to a personal computer. This allows (a) recharging the internal battery of the reader, and / or (b) transmitting data to and from the computer for data storage, in addition to processing the data, displaying the data or simply because the computer performs the processing of temperature data in the system. When the reader or the data processor finds that an expected model of ovulation is not being adjusted, or needs additional user interaction, they can cause the user to connect to a personal computer. The device can appear on the computer as a USB "driver" storage device, with software and manuals for the device available in the driver, thus removing the need for separate software (eg CDs) to be carried with the device . The software can provide a more extensive user interface, which can operate by connecting to the Internet to perform software and firmware updates. Optionally, the user's data can be uploaded to the Internet for analysis by third parties, for example, medical practitioners.

The computer interface aspect of the reader allows the system to act as a training system for the user in the measurement of more subjective physiological parameters, such as cervical fluid quality, since training software can incorporate thermal history and other user data. This reduces the reliance on physical education by a third party, which is often considered invasive or embarrassing. Since the user becomes more adept at measuring these additional parameters, the statistical model for predicting ovulation is altered by providing more weight to these observations. This allows a progressive reduction in the "safety window" around the ovulation period, during which abstinence should be practiced in order to prevent pregnancy. The data recorder described herein may be a temperature data logger of the human or animal body incorporated in a usable adhesive portion 407, 503 as shown in Figures 4 and 5. The adhesive 411 may be selected from any of the adhesives. of known skin and is preferably hypoallergenic in a manner that minimizes the risk of an adverse reaction with the skin 401 of the user. The patch preferably houses the data logger 403, 501 in a bag configuration that allows the data logger to be removed and installed in a patch new when it is advantageous - for example, when the adhesive loses its tack or the user wants a new patch. Figure 5 shows an opening 507 through which the data logger 501 can be removed and installed. Alternatively the data logger could be sealed in the patch, which may be convenient if the patch and the data logger are disposable. In a preferred embodiment the patch is approximately circular, approximately 2 cm in diameter and colored skin. To thermally isolate the body temperature sensor from changes in the environment in temperature, the patch may have a thermally insulating region 405 (such as a soft foam liner) that extends over the part of the data logger that is opposite to the face of the data logger held against the body. The patch may have an opening 509 through which a thermal conduction study 409, 505 of the data logger may protrude and make physical contact with a body to which the patch adheres. In figure 5 this forms part of the opening 507 through which the data logger can be inserted into the patch. If the data logger does not have a thermal conduction rod, it is generally desired that the patch (and possibly the data logger enclosure) be more thermally conductive in the region between the sensor body temperature and body itself than in other places on the patch / envelope. This can be achieved through the choice of materials used in the patch / envelope and / or the manufacture of the patch / envelope so that the material is thinner than in the region on the temperature sensor. The patch constructions described above can be conveniently supplied as a sterile, disposable device. Alternatively, the data logger can be incorporated into a band (such as can be worn around the arm) or a garment, or the data logger can be held in place by a configuration of belts or bands. The band would preferably be worn around the forearm with the temperature sensor located on the inside of the arm, next to the armpit. In order to be able to precisely measure small variations in body temperature it is particularly important that the data logger is repositioned in the same place (the measuring spot) in the body of the user each time the user renews the band. The band may therefore have marks in order to assist the user in correctly positioning the data logger maintained within the band. Neoprene, which is comfortable to wear for long periods and is a good thermal insulator is a particularly suitable material for the band. Various temperature sensors can be kept in a ring in the band. This can help mitigate the effects of poor rotation positioning of the band by the user. Typically there will be a known variation in temperature around the arm (expressed) around which the band is carried. This variation can be measured and stored as a profile for the particular user in the data logger, or more preferably in the data processor to which the temperature measurements are sent by processing. The profile allows the temperature measurements of each of the sensors to later be correlated with their position around the arm in order to determine which sensor is closest to the "measurement spot". This may also be desirable to use the known temperature profile to interleave between temperature measurements in order to more precisely determine the temperature at the measurement spot each time the band is replaced. These calculations can be made in the data processor. In the embodiments illustrated in Figures 3, 4 and 5 the temperature and air sensors are incorporated into the main body of the data logger by itself. In this mode it can be thermally conductive portions of the sensor data recorder envelope of temperature, or it can be thermally conductive studies by coupling the temperature sensors to the body, as shown. However, temperature sensors can be external to the main body of the data logger and wire to the data logger. Similarly, airs can be external to the main body of the data logger - perhaps to improve data and energy transfer. The temperature and / or aerial sensors can be integral to the patch / band and connected to the data recorder by wires. Preferably the data logger itself is encapsulated in a sealed enclosure to protect the data logger components from shock, liquids and corrosion. To allow the devices to be re-used by different users, it is also advantageous if the data logger can be sterilized in an autoclave. Preferably the shell has an outer layer of silicone, or other inert material. The silicon may be of varying thickness on the envelope such that it is a thinner layer than silicon (perhaps 0.1 mm) on the temperature sensor and a thick layer of silicon (maybe 0.5 mm) on other areas of the envelope . The thick layer of silicon can help to thermally insulate the sensor. Silicon can be adulterated with metal particles on the temperature sensor in order to improve the thermal conductivity of the silicon in the region. The silicone or other protective material may preferably be injection molded or insert molded, impermeable and / or biocompatible. As discussed above, the data logger may have a study of a highly conductive material (eg, metal) that exits some or all of the form through the envelope / silicon data recorder in order to improve the thermal coupling between the temperature sensor of the data logger and the body to which this applies. In cases where a core estimate of body temperature is required, but measurements are taken at an external point in the body, an improvement over a simple measurement of skin temperature can be made. If the temperature of the skin is measured under a patch of thermal insulation, and the temperature on the outer surface of the insulator is also measured (that is, two measurements are taken), an estimate of the differences between the temperature of the skin and the core of body temperature is possible. The simplest application is to apply a constant factor to the temperature difference between the two sensors, that is, Core = Tpiel + k (Tpiel - Texterior). A more complicated, but accurate, method is to take into account cases where the ambient temperature is greater than, as well as less than, skin temperature, and also to make the correction a non-linear function. Such corrections are preferably applied in the data logger so that only the estimated resulting core temperature needs to be stored in the data logger. Alternatively both sets of temperature data can be stored and corrections can be applied in the data processor to which the temperature data is sent. By calibrating such a patch device against core body temperature (as measured by any conventional technique) under a variety of external temperature conditions, a more accurate correction system can be worked out. Alternatively, the calibration can be performed according to any of the following methods in order to determine the correction function required to produce an approximately constant core body temperature from the data: 1. Application of known thermal gradients through of the patch and measure the response of the two thermometers. 2. Expose the outdoor temperature sensor to a range of temperatures while using the patch by a user. It is important that the temperature applied varies more rapidly than the temperature of the body can respond to changes in temperature. 3. Analyze temperature measurements during use for rapid natural variations in external temperature compared to the measured skin temperature. This method is preferably performed in the data logger and can be used to continuously adjust the correction function in response to environmental changes. In one mode, the calibration calculations are performed in a data reader or data processor (to which the reader can be connected) as follows: 1. The data reader transmits a command to the data logger instructing it to enter a mode of calibration. 2. A calibration process is started and the data logger transmits the temperature data from the temperature sensors in real time. 3. The data reader or a data processor to which the data reader is connected calculates the correction function. 4. The data reader transmits the parameters of the calibration function to the data logger for use in extrapolating the core body temperature from the skin and the external values of the temperature sensor. The calibration factors can be stored in the data logger (perhaps after being transmitted from the data reader if the calibration calculations are made in the reader / data processor). The thermal properties - or derived numbers representing the properties - of the data logger cover and / or the patch / band, can be stored in the data logger or data reader / processor for use in the processing of the measured data . The thermal properties may be determined during a calibration process or may be available if the data recorder cover and / or the patch / band uses materials having known properties. Knowledge of these properties can, for example, allow the data processor to calculate a theoretical temperature gradient through the data logger and its covers which can be used to extrapolate a core body temperature. For other sensor types, the relevant physical properties will be stored instead: for example, the light transmission or acoustic properties of the covers in which the data logger is incorporated can be stored. The calibration principles discussed above also apply to calibration measurements of other physical parameters by other types of sensors. A data logger that has a temperature sensor for skin and a temperature sensor for the environment (or two sensor inputs for two temperature sensors external to the data logger itself) can be incorporated in a patch or band as described above, but with an additional opening or region of increased thermal conductivity on the outside temperature sensor so as to better externally couple that temperature sensor to the external environment. A further improvement can be made by using three or more temperature sensors, located in positions with different thermal parameters, such as local heat capacity and conductivity. For example, if a sensor is on the body side of a device, with low thermal resistance to the body, a sensor is on the external side of the device, with low thermal resistance to the external environment, and a sensor is in the middle of the device With a comparatively high thermal resistance at any point and a comparatively high local thermal mass, a suitable calibration scheme can be used to provide a more accurate estimate of the core temperature. The calibration scheme can be pre-set, or it can be based on an empirical or adaptation algorithm. The configurations of the data recorder described above are not limited to data loggers designed to measure the temperature of the skin / body of an animal or human and are generally applied to measure the temperature or any other physical parameter of a body, either flora, fauna, machine, rock etc. It is advantageous in a data logger for a system to determine the ovulation point in a female subject, that the temperature data from the data logger be combined with the data which indicate the activity state of the female subject . (The term "female subject" as used in this application refers to both animal and human female subjects.) Particularly with an externally used patch or data record band (although it is also a matter with a data recorder). implanted data) the identification of the fall in body temperature that indicates a decrease in the "basal body temperature" is difficult without being able to correlate the temperature data with the user activity of the female subject. When the user is awake and moves around the flow of air surrounding the data recording device and on the skin, the temperature of the skin may decrease. In contrast, when a user is asleep, the data logger tends to be well insulated and the skin at a warmer temperature (although this is often the best time to take temperature measurements because core temperatures and temperature are stable). skin) . And when the user exercises or has a fever there can be increases in both core body temperature as of the skin. It is more preferable to measure body temperature when the user is at rest as this helps to avoid erroneous measurements due to changing temperature conditions unrelated to variations in basal body temperature. It is advantageous to measure movement, either in the data logger or otherwise, and to relate this data to the measured temperature data in the data processor in order to better determine the user's basal temperature. For example, the basal temperature can be determined from the lowest temperature measured during periods of low motion that last more than 30 minutes. Motion data can be captured in the data logger itself - for example, by including an accelerometer in the data logger. In this case, either the acceleration / vibration data can be recorded or the knowledge of the force of gravity can be used to measure the "tilt" of the data logger, as is known in the art. When the user moves, the inclination will change, and so the movement can be inferred. Alternatively, some other motion detection means may be used, such as a motion detection video camera coupled to the data processor, a pulse sensor (which indirectly indicates when the user moves / exercises), and a sensor in a bed / mattress which detects the movement on the bed (for example, the user rolls up). Preferably, the movement of the user in the data logger itself is measured. During periods of high movement, the data logger may adjust to not recording any temperature data. The movement data themselves do not therefore need to be recorded in the data logger - they are used to determine when to measure and record the temperature and when not to do so. This makes the use of memory effective in the data logger. Alternatively, both the movement and the temperature can be recorded in the data logger and the data processor can subsequently combine these data sets in order to determine which portions of the temperature data probably correlate closely with the actual body temperature of the data. user's core, and what portions of the data are likely to be less reliable. Doing this in the data processor allows a more sophisticated method to be taken. For example, more complex algorithms can be applied that allow short periods of movement (such as the user who changes position in their sleep) to be monitored when determining a relatively long period of low movement in which they are likely to have taken good quality temperature measurements. Those measurements of temperature taken during relatively long periods of low movement are preferably used in determining the basal body temperature (or some analogous thereof) and the remaining data may be discarded. A preferred method will now be described whereby the temperature data of a data logger can be processed in a data processor in combination with the movement information for the user (from either the data logger or external measurements). 1. Identify periods of low movement in the user of duration at least one predetermined extension (for example, 30 minutes). 2. Identify the temperature measurements that correspond in time to the window of low movement. 3. Calculate the average of those measurements to produce an average resting temperature. This processing is preferably carried out on the data of each day (or night) for which there is data at the time so as to provide an estimate of the daily basal temperature of the user. Temperature data may be limited to those measurements taken when the user is likely to be asleep or at rest by only processing temperature data taken between certain hours (eg, 11pm to 6am). Or the user can simply use the data recorder (such as a patch, arm band etc.) when sleeping. It has been found that a reliable estimate of the basal body temperature can be determined from the temperature data taken while the user sleeps. However, sometimes the user may only sleep for a short period, or sometimes the temperature data is of poor quality for part of the sleep period. In these cases it is possible to estimate the basal body temperature of the user by extrapolating the slow decrease in body temperature that occurs during the user's sleep so that an estimate of the minimum body temperature that the user would have reached if there is could sleep for a sufficient period of time (or have temperature data of good enough quality). This minimum can be estimated by using techniques known in the art from the slope of the temperature-time curve: for example, the change ratio of the slope of the curve can be used to anticipate when a minimum temperature occurs. bodily. The estimate can be improved by comparing the incomplete temperature data with the temperature-time curves taken during the previous sleep periods: for example, knowledge of how much it typically takes to reach the user's body temperature to anticipate when that happens. minimum for a given initial temperature and slope of the curve of temperature-time. It is clear from the above discussions that a data logger according to the present invention can have any number of inputs, each of which can be an input of any type of sensor (such as a temperature sensor, accelerometer). When captured by a data reading device, the data logger transmits one or more of the sensor data sets. The data logger can transmit the data to the reader in any of several ways, including: transmitting only those data sets required by the reader, 'transmit the data sets in a predetermined order, and transmit the measurements in order (or order) inverse) in which they were taken. The data logger could have a programmable data logging interval, which is set when the patch is first applied to the patient (by means of a command from the data reader to the data logger, for example). The data logger can then record the data at the specified intervals until it is instructed to stop (or until the battery runs out). In some embodiments, the data logger stores a time stamp with each measurement, or stores a time stamp each time the data logger (re-) initiates the registration.

All of the embodiments of a data recorder described above in relation to a data logger for use in a system for determining the ovulation point in a female subject are generally applied to data recording devices which may have any number of applications and sensor types. The temperature data stored in a data logger represents a thermal history of the body to which it joins in time. For some applications, such as determining the ovulation point in a subject of the female sex (human or animal), it is not necessary to measure the temperature of the body at each point throughout the day. In this case, it is convenient for the user to incorporate the data logger into a band which is worn around the forearm, but which can be removed for showering or playing sports. In these cases, the data logger can stop the recording when (for example) the temperature drops below a certain level (because the sensor is no longer in contact with the skin), or when a button is pressed on the recorder data / arm band, or when receiving a command from the data reader device, to give a few examples. A patch configuration (possibly disposable) is useful in medical applications, when it is important to have complete and uninterrupted temperature measurements of the patient's body temperature. The high resolution temperature data (both in accuracy of temperature and frequency of measurement) are of use in the diagnosis of various medical conditions, for example certain types of infections, hypothermia or pyrexia. Having access to a complete history of the temperature stored in a data recording device used by a patient can help a doctor to reach an accurate diagnosis more quickly. The applicant hereby separately describes each individual feature described herein and any combination of two or more such features, to the extent that such features or combinations can be carried out based on the current specification as a whole, to the light of general knowledge common to a person skilled in the art, regardless of whether such features or combinations of features solve some of the problems described herein, and without limitation for the scope of the claims. The applicant indicates that aspects of the present invention may consist of some individual aspect or combination of aspects. In view of the above description, it will be apparent to a person skilled in the art that various modifications may be made within the scope of the invention. It is noted that in relation to this date, the best known method for carrying out the aforementioned invention is that which is clear from the present description of the invention.

Claims

CLAIMS Having described the invention as above, the content of the following claims is claimed as property: 1. A data recording device for in situ measurement of one or more physical parameters, characterized in that it comprises: a power source; one or more sensors to measure one or more physical parameters; a data store for storing representations of at least some of the measured values of one or more physical parameters; control logic configured to write representations of at least some of the measured values to the data store and configured to read data from the data store during data transmission; an antenna; and a transmitter coupled to the antenna and configured to transmit the stored data by passive transmission. The data recording device according to claim 1, characterized in that the power source is a rechargeable power source and the transmitter is configured to supply at least part of the electromagnetic energy received in the antenna to the power source rechargeable so that it recharges the rechargeable power source. The data recording device according to claim 2, characterized in that the data recording device further comprises selector logic and the transmitter is configured to supply at least part of the electromagnetic energy received in the antenna to the source of Rechargeable energy if the selector logic selects that the rechargeable power source is rechargeable. . The data recording device according to claim 3, characterized in that the selector logic is configured to select that the rechargeable power source is rechargeable if the voltage across the power source falls below a predetermined level. 5. The data recording device according to any of the preceding claims, characterized in that at least some of the representations of the measured values are a difference between a previously measured value and a subsequently measured value of a physical parameter. The data recording device according to any of the preceding claims, characterized in that the control logic is configured to write at least some of the representations of measurement values to the data store in conjunction with a time stamp that indicates the time in which the respective measurements are taken. The data recording device according to any of the preceding claims, characterized in that each sensor is configured to measure one or more physical parameters at a predetermined frequency. The data recording device according to any of the preceding claims, characterized in that the control logic has a first mode of operation in which it is operated to write representations of measurement values to the data store and a second mode of operation in which this is not operated to write representations of measurement values to the data warehouse, the control logic consumes more energy in the first mode than in the second mode, and the control logic is configured to enter the second mode of operation when one or more of the following conditions are met: (a) a predetermined length of time elapses after writing to the data store; (b) when the value to be measured from one selected one of one or more physical parameters changes between the measurements by more or less the predetermined amount; (c) when the value to be measured from one selected from one or more physical parameters is a value greater than or less than a predetermined value. 9. The data recording device according to claim 8, characterized in that the control logic is configured to enter the first mode at a predetermined length of time after entering the second mode. 10. The data recording device according to claim 8, the data logger further characterized in that it includes comparison circuitry configured to determine when the value being measured from one selected one of one or more physical parameters changes between measurements by more or less the predetermined amount, and the comparison circuitry is configured to, in response to this determination, cause the control logic to enter the first mode and write representations of at least some of the measured values to the data store. The data recording device according to any of the preceding claims, further characterized in that it comprises means for averaging a set of measurement values of one selected one of one or more physical parameters and causing the control logic to write a representation from the average of the set of measurement values to the data warehouse. 12. The data recording device according to any of the preceding claims, characterized in that the physical parameters are one or more of temperature, pressure, pH, light intensity, sound pressure, movement, spectral light quality, orientation or inclination of the data logger, and vibration. The data recording device according to any of the preceding claims, characterized in that the data store of the data logger is configured to store additional data. The data recording device according to claim 13, characterized in that the additional data includes personal and / or medical information. The data recording device according to any of the preceding claims, characterized in that at least some of one or more physical parameters are physiological parameters and the data recording device is incorporated into one of: (a) an appropriate package for implant in a human or animal body; (b) an adhesive patch suitable for use on the skin; and (c) an item of clothing or other item to be worn; (d) a protective envelope. 16. The data recording device according to any of the preceding claims, characterized in that one of one or more sensors is a first temperature sensor. The data recording device according to claim 16, characterized in that one of one or more sensors is a second temperature sensor, and the first temperature sensor is configured to measure the temperature of a human or animal body and the Second temperature sensor is configured to measure the ambient temperature of the human or animal body. The data recording device according to any of the preceding claims, characterized in that one of one or more sensors is an accelerometer or other means for measuring movement of the data recording device or the body to which the accelerometer or other means to measure movement joins. The data recording device according to any of the preceding claims, characterized in that the control logic is configured to write a representation of a value that is measured from a first one selected from one of one or more physical parameters to the store of data only when the variation in previously measured values of a selected second of one or more physical parameters is less than a predetermined value. 20. The data recording device according to any of the preceding claims, characterized in that the control logic is configured to write a representation of a value that is measured from one selected one of one or more physical parameters to the data store only when the value being measured changes between the measurements by more than a predetermined amount. 21. The data recording device according to claim 20, characterized in that the representation is a time stamp indicating the time in which the change was measured. 22. A system for in situ measurement of one or more physical parameters characterized in that it comprises: the data recording device according to any of the preceding claims; and a data reading device comprising a receiver configured to receive at least some of the data stored from the data recording device by passive transmission. The system according to claim 22, characterized in that the data logger is configured to transmit at least some of its stored data when the energy received by the receiver from the data reader exceeds a predetermined level. 24. The system according to claim 22, characterized in that the data logger is configured to transmit at least some of its data stored in response to an appropriate command from the data reader. 25. The system according to claim 24, characterized in that the command indicates which of the data stored the data recorder to be transmitted. 26. The system according to any of claims 22 to 25, characterized in that each sensor is configured to measure one or more physical parameters at a predetermined frequency and the data reader is operated to transmit a signal to the data logger to establish this frequency. 27. A data recording device or system according to any of the preceding claims, characterized in that the data store of the data logger is configured to store additional data. 28. The data recording system or system according to claim 27, characterized in that the additional data includes personal and / or medical information. 29. The system according to claim 27 or 28, characterized in that the data logger is configured to transmit at least some of the additional data once an appropriate command is received from the data reader. 30. The system in accordance with any of the claims 27 to 29, characterized in that in response to receiving an appropriate command from the data reader, the data logger is configured to (a) overwrite at least some of the additional data with the data transmitted in conjunction with the command, or (b) write data transmitted together with the command to the data store as extra extra data. The system according to any of claims 22 to 30, characterized in that the data reader is operated to transmit an authentication code to the data logger. 32. The system according to claim 31, characterized in that at least part of the authentication code is determined depending on the identification code of the data logger. 33. The system according to claim 31, characterized in that at least part of the authentication code is determined depending on the identification code of the data reader. 34. The system according to any of claims 31 to 33, characterized in that the data logger houses a set of valid authentication codes and the data logger is configured to transmit at least some of its stored data to the data reader only. if you receive a code of valid authentication 35. The system according to any of claims 22 to 34, characterized in that the data logger is configured to perform public key authentication of the data reader, or vice versa, and the data logger is configured to transmit at least some of its data. data stored to the data reader only if it receives a valid response. 36. The system according to any of claims 22 to 35, characterized in that the data reading device comprises input means for entering data in the reader. 37. The system according to any of claims 22 to 36, characterized in that the data reading device is configured to store at least some of the data received in the data reading device. 38. The system according to any of claims 22 to 37, characterized in that the data reading device can be operable to transmit by wire or wireless communication at least some of the data received from the data logger to one or more than one Internet server, a personal computer (which includes a laptop, desktop computer, PDA, smart phone or computer) hand), a storage device, or any other data processing device. 39. The system according to any of claims 22 to 38 depending on claim 17, characterized in that the data reading device is configured to process each value that is measured from the first temperature sensor depending on the corresponding measured value of the second temperature sensor so that an estimate of the core body temperature of the human or animal body is formed that the first temperature sensor is configured to measure. 40. The system according to any of claims 22 to 39 depending on claim 18 and as further dependent on claim 16, characterized in that the data reading device is configured to ignore at least some of the measured values of the first sensor of temperature that are measured when the variation in measurement values of the accelerometer or other means for measuring movement exceeds a predetermined value. 41. The system according to any of claims 22 to 39 depending on claim 18 and as further dependent on claim 16, characterized in that the data reading device is configured to ignore at least some of the measured values of the first sensor of temperature that are measured when the measured values of the accelerometer or other means for measuring movement exceeds a predetermined value. 42. A system for determining the ovulation point in a subject of the female sex characterized in that it comprises: a data recording device comprising: a first temperature sensor for measuring a first temperature of the subject of the female sex; a data store for storing one or more first temperature measurements as a set of first physiological data; control logic configured to store representations of first temperature measurements in the data warehouse; a transmitter configured to transmit at least some of the stored data; a data reading device comprising: a receiver configured to receive at least some of the data stored from the data recording device; and a data processor having operable input means for receiving at least one other set of physiological data; wherein the data processor is configured to combine the first temperature data of the data reading device and at least one other data set physiological so that an indication of the ovulation point is formed. 43. The system according to claim 42, characterized in that the data recording device is incorporated in one of: (a) a package suitable for implantation in a human or animal body; (b) an adhesive patch suitable for use on the skin; and (c) an item of clothing or other article to be worn; (d) a protective envelope. 44. The system according to claim 42 or 43, characterized in that at least one other physiological data set includes at least one of cervical fluid quality data, hormone level data, and data indicating dates of at least one menstruation previous. 45. The system according to any of claims 42 to 44, characterized in that the data processor is operated to combine the first temperature data and at least one other physiological data set by means of an ovulation prediction algorithm that is configured to assign a different statistical weight to each of the data sets. 46. The system according to claim 45, characterized in that the statistical weights are based on the degree of previous correlation between the ovulation point indicated by the data sets and the current ovulation point. 47. The system according to any of claims 42 to 46, characterized in that the data processor or data reader is operated to cause the user to provide additional physiological data sets in the data processor input means. 48. The system according to any of claims 42 to 47, characterized in that the data reading device comprises a housing and the data processor is incorporated into the housing of the data reading device. 49. The system according to any of claims 42 to 48, characterized in that the data reading device is a portable device. 50. The system according to any of claims 42 to 49, characterized in that the data reading device includes a memory for storing the data received from the data recording device. 51. The system according to any of claims 42 to 50, characterized in that the data reading device includes a screen for displaying the data received from the data recording device. data 52. The system according to any of claims 42 to 51, characterized in that the data reading device is configured to make available at least some of the data received from the data logger by wired or wireless communication with the data processor. 53. The system according to any of claims 42 to 52, characterized in that the data recording device further comprises an accelerometer or other means for measuring movement of the subject of the female sex and the control logic is further configured to store representations of the movement measurements in the data store, the data processor it is operated to ignore at least some of the temperature measurements that are measured when one of the following conditions was true: (a) the variation in the movement measurements exceeds a predetermined value; (b) the movement measurements exceed a predetermined value. 54. The system according to any of claims 42 to 52, characterized in that the data recording device further comprises an accelerometer or other means for measuring movement of the subject Female gender and control logic is further configured to not store at least some of the representations of the first temperature measurements in the data store when one of the following conditions is true: (a) the variation in previous movement measurements exceeds a predetermined value; (b) at least one pre-move measurement exceeds a predetermined value. 55. The system according to any of claims 42 to 52, characterized in that one of at least other sets of physiological data received in the data processor input means is movement data for the female subject and the processor of data is operated to ignore at least some of the first temperature measurements that are measured when one of the following conditions was true: (a) the variation in the measurements represented by the movement data exceeds a predetermined value; (b) the measurements represented by the movement data exceed a predetermined value. 56. The system according to any of claims 42 to 55, characterized in that the data recording device further comprises a second temperature sensor and the control logic is further configured to store representations of the second measurement. of temperature in the data warehouse. 57. The system according to claim 56, characterized in that the second temperature sensor is configured to measure the ambient temperature of the female subject and the data reading device is configured to process each measurement of the first temperature sensor depending on the corresponding measurement of the second temperature sensor so that an estimate of the core body temperature of the female subject is formed. 58. The system according to any of claims 42 to 57, characterized in that the data processor is operated to make a first determination depending on the data from the data logger and / or at least other physiological data sets as if the The subject of the female sex reaches a basal body temperature and, if the result of the first determination is negative, the data processor is configured to form an estimate of the basal body temperature depending on at least one of the following: (a) a relationship of change in any of the temperature measurements; (b) a change ratio in the rate of change in any of the temperature measurements; (c) data that represent previous variations in temperature when the temperature of the female subject it approaches a basal body temperature. 59. The system according to any of claims 42 to 58, characterized in that the data logger is configured to transmit at least some of its stored data to the data reader by wired or wireless transmission. 60. A package characterized in that it comprises a data recording device, the data recording device including: a first temperature sensor for measuring a first temperature; a data store for storing one or more first temperature measurements; control logic configured to store representations of first temperature measurements in the data warehouse; and a transmitter configured to transmit at least some of the stored data; and the package further comprising first and second portions, the data recording device is maintained between them; wherein the first temperature sensor is adjacent to the first portion and at least one region of the first portion next to the first temperature sensor has a greater thermal conductivity than the second portion. 61. The package according to claim 60, characterized in that the face of the first portion opposite the data logger supports a layer of adhesive in order to allow the package to be attached to an object or body of a human or animal such that the The first temperature sensor is close to the object or body. 62. The package according to claim 60 to 61characterized in that the package further comprises a band or strip arrangement configured to fit around a part of a human or animal object or body and, in use, maintain the package to the human or animal object or body such that the first sensor temperature is close to the object or body. 63. The package according to any of claims 60 to 62, characterized in that the first portion has a localized opening such as to expose the first temperature sensor of the data recording device. 6 The package according to any of claims 60 to 63, characterized in that the first portion has an opening through which the data recording device can be inserted or removed. 65. The package according to any of claims 60 to 64, characterized in that the first and second portions of the package are disposable. 66. The package according to any of claims 60 to 65, characterized in that the data recording device further includes a power source and the first temperature sensor is mounted against the power source. 67. The package according to any of claims 60 to 66, characterized in that the data recording device further includes a second temperature sensor for measuring a second temperature. 68. The package according to claim 67, characterized in that the second temperature is the ambient temperature of the package. 69. The package according to any of claims 67 to 68, characterized in that the second portion has a localized opening as to expose the second temperature sensor of the data recording device.